Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)

NCT00271726 | Unknown

• 1 other identifier: OTEC Pilot 1 KKS MR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires. The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.

Conditions

Colles' Fracture; Radius Fractures

Keywords

distal radius fracture; extraarticular Colles fracture

Outcome Measures

Primary Outcomes (1)

• Functional status measured by DASH questionnaire

Secondary Outcomes (5)

• Pain

• Range of motion (ROM)

• Grip strength

• Radiological parameters

• Feasibility

Interventions

Osteosynthesis with palmar locking plate PROCEDURE

Osteosynthesis with external fixator PROCEDURE

Osteosynthesis with Kirschner wires PROCEDURE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
• Age 65 years or older
• Patient agreed with and signed the "informed consent" form

You may not qualify if:

• Fractures older than 7 days (more than 1 week between injury and treatment)
• Other injuries of the hand
• Other relevant injuries of the upper extremities
• Open fracture
• Patients with one hand missing
• Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
• Previous skeletal injury or severe soft tissue injury of the arm
• History of drug or alcohol abuse
• Patients unlikely to cooperate or attend all scheduled visits
• Patients who have participated in any other device or drug clinical trial within the previous month
• Patients with legal incompetence

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Philipps University Marburg: collaborator

Study Sites (1)

Department of Trauma and Hand Surgery, University Hospital

Düsseldorf, D - 40225, Germany

RECRUITING

MeSH Terms

Conditions

Colles' Fracture; Radius Fractures; Wrist Fractures

Interventions

Fracture Fixation, Internal; External Fixators; Bone Wires

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Fractures, Bone; Forearm Injuries; Arm Injuries; Wrist Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Internal Fixators; Prostheses and Implants

Study Officials

• Michael Schädel-Höpfner, MD

  Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Schädel-Höpfner, MD

CONTACT

+49 211 8104405; schaedel@uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 4, 2006
• Study Start: November 1, 2005
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

DE (1)